Investigating the effect of intranasal corticosteroids on the incidence of invasive fungal sinusitis in patients receiving stem cell transplantation: A randomized clinical trial study
effect of intranasal corticosteroids on invasive fungal sinusitis in bone marrow transplant
Design
A controlled, double-blind, randomized, phase 3 clinical trial with parallel groups on 426 patients. The rand function of Excel software was used for randomization
Settings and conduct
patient who received bone marrow transplant referred with acute rhinosinusitis to Taleghani hospital of Tehran were randomly divided in two groups with block randomization method to intervention and control group. This research is a double blind study that patients and physician and data analyzers are blinded to study intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients who were at least 18 years old. Recipients of allogeneic or autologous hematopoietic stem cell transplant in the past 3 months;
exclusion criteria: evidence of active fungal sinusitis or previous fungal sinusitis, Patients taking systemic antifungal medications, History of facial trauma, History of previous sinus and nose surgery, Patients diagnosed with chronic rhinosinusitis with or without nasal polyposis
Intervention groups
Patients in the intervention group receive fluticasone propionate nasal spray producted by kooshan pharmed company at a daily dose of 200 micrograms, and patients in the control group receive a placebo nasal spray that is similar in appearance to fluticasone spray. The spray is inhaled twice a day, one puff each time, equivalent to 100 micrograms, in each nostril for 8 weeks. The spray is shaken before use and the tip of the spray is kept away from the nasal septum.
Main outcome variables
incidence of invasive fungal sinusitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200926048841N4
Registration date:2026-06-12, 1405/03/22
Registration timing:registered_while_recruiting
Last update:2026-06-12, 1405/03/22
Update count:0
Registration date
2026-06-12, 1405/03/22
Registrant information
Name
mahboobe asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2640 5257
Email address
ma_asadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-03-07, 1404/12/16
Expected recruitment end date
2026-07-07, 1405/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of intranasal corticosteroids on the incidence of invasive fungal sinusitis in patients receiving stem cell transplantation: A randomized clinical trial study
Public title
The effect of intranasal corticosteroids on the incidence of invasive fungal sinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who were at least 18 years old at the time of the study
Recipients of allogeneic or autologous hematopoietic stem cell transplant in the past 3 months
A persistent absolute neutrophil count of less than 1000 cells per cubic millimeter for a minimum continuous period of seven days, documented by at least two consecutive laboratory measurements
Exclusion criteria:
Patients who had evidence of active fungal sinusitis or previous fungal sinusitis based on clinical, radiological, or microbiological criteria,
Patients taking systemic antifungal medications, including prophylactic or curative therapy
History of facial trauma that required surgical intervention
History of previous sinus and nose surgery
Congenital anomalies of the skull and face.
Patients diagnosed with chronic rhinosinusitis with or without nasal polyposis
Patients with known hypersensitivity to fluticasone propionate or any component of the nasal spray formulation.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
426
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method. Given the block size of 2, there are two ways to assign participants to a block: AB or BA. (A) stands for fluticasone propionate spray; (B) stands for placebo spray. Using Microsoft Excel software we produce 213 numbers.
For even numbers AB combination and for odd numbers BA combination are chosen.
Blinding (investigator's opinion)
Double blinded
Blinding description
fluticasone propionate spray and placebo spray are identical in shape and package.Patients were blinded to which group they entered,but they were told that they could use nasal spray fluticasone propionate or placebo spray.The researcher and the author of the article are blinded to which group A or B belong to intervention group. The evaluations after the operation were performed by a person who was blinded to the patient group.The statistical analyzer was also blinded to the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of medical sciences
Street address
Shahid Beheshti university of medical science, Erabi Ave, Velenjak ,
City
Tehran
Province
Tehran
Postal code
1916665354
Approval date
2026-02-08, 1404/11/19
Ethics committee reference number
IR.SBMU.RETECH.REC.1404.1085
Health conditions studied
1
Description of health condition studied
Stem cells transplant patient
ICD-10 code
Z94.84
ICD-10 code description
Stem cells transplant status
2
Description of health condition studied
Acute myeloblastic leukemia
ICD-10 code
C92.0
ICD-10 code description
Acute myeloblastic leukemia
3
Description of health condition studied
Acute myeloid leukemia with multilineage dysplasia
ICD-10 code
C92.A
ICD-10 code description
Acute myeloid leukemia with multilineage dysplasia
Primary outcomes
1
Description
Incidence of invasive fungal sinusitis
Timepoint
before intervention and 2 months after intervention
Method of measurement
mucosal biopsy and pathology assessment
Secondary outcomes
1
Description
total mortality rate
Timepoint
2 months after intervention
Method of measurement
checking patients' record
2
Description
mortality rate because of invasive fungal sinusitis
Timepoint
2 months after intervention
Method of measurement
mucusal biopsy and checking patients' record
3
Description
duration of hospitalization
Timepoint
2 months after intervention
Method of measurement
checking patients' record
4
Description
duration of hospitalization in ICU
Timepoint
2 months after intervention
Method of measurement
checking patients' record
5
Description
duration of neutropenic status
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Lab tests and patients' record
6
Description
endoscopic sinus surgery rate
Timepoint
2 months after intervention
Method of measurement
checking patients' record
Intervention groups
1
Description
Intervention group: Patients who receive kooshan pharmed Company's fluticasone propionate nasal spray at a daily dose of 200 micrograms (100 micrograms in each nostril, twice a day) for 8 weeks. The doctor instructs patients to shake the spray before use and to keep the tip of the spray away from the nasal septum when using it inside the nose.
Category
Treatment - Drugs
2
Description
Control group: They receive a placebo nasal spray producted by koosha pharmed company containing a rinse serum that is similar in appearance to fluticasone propionate spray (one puff in each nostril twice a day) for 8 weeks. The doctor instructs patients to shake the spray before use and to keep the tip of the spray away from the nasal septum when using it inside the nose.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Mahboobe Asadi
Street address
Taleghani Hospital,Erabi Ave,Velenjak
City
Tehran
Province
Tehran
Postal code
1916665354
Phone
+98 911 114 5154
Email
mahboobeh_farvardin@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, , Vice Chancellor for Research and Technology,Erabi Ave,Velenjak
City
Tehran
Province
Tehran
Postal code
1916665354
Phone
+98 21 2243 9788
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahboobe Asadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Taleghani hospital,Erabi Ave,Velenjak
City
Tehran
Province
Tehran
Postal code
1916665354
Phone
009821230311
Email
Mahboobeh_farvardin@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahboobe Asadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Erabi ave,Velenjak
City
Tehran
Province
Tehran
Postal code
1916665354
Phone
+98 21 2303 1317
Email
mahboobeh_farvardin@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahboobe Asadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Erabi Ave ,Velenjak
City
Tehran
Province
Tehran
Postal code
1916665354
Phone
+98 21 2303 1317
Email
mahboobeh_farvardin@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
participant data sets are to be shared
When the data will become available and for how long
These data files will become available one year after publication
To whom data/document is available
The data is only available for people working in academic institutions
Under which criteria data/document could be used
The data is only available for people working in academic institutions
From where data/document is obtainable
The data is obtainable from the corresponder author via email
What processes are involved for a request to access data/document
The data is obtainable from the corresponder author via email